Detailed explanation of registration of new polymer chemicals in China

According to the requirements of China's "New Chemicals Environmental Management Registration Method" and "New Chemicals Environmental Management Registration Guide", polymer, as a special type of polymer, may cause lower hazards, and the registration conditions are different from those of general substances, and in most cases there are different degrees of data reduction.

1. Definition of polymer

Polymer means that a substance molecule consists of one or more monomer units in sequence, and the molecular weight distribution of such molecules is within a certain range, and the difference of molecular weight mainly depends on the difference of the number of monomer units. The polymer shall meet the following three conditions:

(1) the molecular weight is not a certain fixed value, but presents a dispersed distribution;

(2) More than 50% (weight percentage) of the molecules contain at least three monomer units, which are connected with at least one other monomer unit or other reactants in the form of covalent bonds;

(3) Molecules with the same molecular weight shall not exceed 50% (weight percentage) of all molecules.

At the same time, substances meeting the above three conditions can be registered as new chemical substances according to the requirements of polymers. According to the nature of polymer, the possible registration types are filing, simple registration and routine registration, and the requirements of the three types of registration data are gradually increased. You can gradually judge according to the registration strategy and choose the appropriate registration type.

2. The polymer registration strategy

3. The polymer filing situation

1, the annual production or import of new chemical substances is less than 1 ton;

2. New chemicals, monomers or polymers with a reactant content of not more than 2%, or polymers of low concern.

For the first case, it is only necessary to meet the conditions that the annual production or import volume is less than 1 ton, and the requirements for filing materials are the same as those for general substances.

In the second case, the filing is only for polymers. In addition to meeting one of the two polymer conditions, polymers need not be excluded from the filing, and the annual production or import volume is not limited.

 

4. Polymer filing data requirements

Filing materials	Record form of new chemical substances
	Legal person certificate or business license, agency contract or agreement (with agent), power of attorney (with authorization)
	Conformity with polymer record certification materials *: A list of monomers/reactants B molecular weight distribution diagram C polymerization mechanism process D, the application material does not belong to the discrimination and explanation materials of polymer record exclusion
	Other information on environmental and health hazard characteristics and environmental risks that have been mastered

* According to the first case for the record, do not need to provide relevant documents.

Polymers meeting the second filing situation:

Type	Definition
2% Polymer	(1) The polymer itself is not in the List, but the weight percentage of all new chemical monomers/reactants of the polymer is less than or equal to 2%.
	(2) The polymer itself is not in the List, but all monomers/reactants of the polymer are in the List.
Low concern polymer	(1) The number average molecular weight of the polymer is between 1,000 and 10,000. The content of oligomers with molecular weight less than 500 is less than 10%, and the content of oligomers with molecular weight less than 1,000 is less than 25%. At the same time, it shall not contain functional groups of high concern or high reactivity, such as heavy metals, cyano (except non-conjugated), acrylate, aziridine, isocyanate (except blocked isocyanate), thioisocyanate, vinyl sulfone, alkoxysilane (alkyl is methyl or ethyl), amine, spiroenamine, halosilane, hydrazine, α/β lactone, methacrylate, etc.
	(2) The number average molecular weight of the polymer is greater than or equal to 10,000. The content of oligomers with molecular weight less than 500 is less than 2%, and the content of oligomers with molecular weight less than 1,000 is less than 5%.
	(3) Polyester polymer: The main chain is a polymer in which monomers are bonded by ester bonds or a polymer in which the main chain is linked by ester bonds.

Exclusion of polymers:

	Cationic polymers (such as polymers containing covalent bonds with phosphonium ions, sulfonium ions and ammonium ions), or polymers that are expected to become cationic polymers in natural water environment (polymers containing amino groups and isocyanates).
	Degradable or unstable polymers, including polymers that are easy to degrade, decompose and depolymerize, and polymers that decompose after production or use.*
	A water-absorbent polymer with a number-average molecular weight greater than or equal to 10,000 Daltons.**
	Fluoropolymers with perfluoroalkyl sulfonic acid groups, perfluoroalkyl carboxylic acid groups or fluorine telomer structural fragments in their structures; A fluoropolymer containing perfluoroalkyl structural fragments covalently bonded to carbon or sulfur atoms in the polymer molecule.
	In addition to impurities, containing other elements than the following allowable elements: Components of polymer must contain at least two elements of carbon, hydrogen, nitrogen, oxygen, sulfur or Silicon (c, h, n, o, s or si). Additional elements: fluorine, chlorine, Bromine and iodine (f, Cl, br and I) covalently bonded to carbon, and chloride, bromide and iodide (Cl- , Br- and I-). Other allowed single ion elements are sodium, magnesium, aluminum, potassium and calcium (Na+, Mg+2, Al+3, K+ and Ca+2), and lithium, boron, phosphorus, titanium, manganese, iron, nickel, copper, zinc, tin and zirconium (Li, B, P)

* Degradation, decomposition or depolymerization refers to chemical changes in which polymers are decomposed into simpler and smaller molecular weight substances through oxidation, hydrolysis, heat, light, solvents or microorganisms.

* * Water-absorbent polymers refer to polymers that can absorb their own weight of water, excluding water-soluble polymers and polymers that can be dispersed in water (including self-dispersed or dispersed).

In both cases, after submitting the data, they will receive the receipt automatically sent by the system, and they can start activities without waiting for the approval of the Ministry of Ecology and Environment. The registration materials that have been put on record will be randomly selected by the Solid Management Center in the later stage, and scientific judgment should be made when putting on record.

 

For polymers that do not meet the filing conditions, simple or routine registration should be done according to the registration amount. Among them, if the annual production or import volume is more than 1 ton and less than 10 tons, simple registration shall be handled; If the annual production or import volume is more than 10 tons, the routine registration shall be handled.

 

In case of routine or simple registration of polymers, besides the registration materials of general substances, the information characterizing polymers, the residual conditions of polymerization monomers, and the metal or cations contained therein shall also be submitted. Polymers that meet the data exemption conditions can be exempted from submitting health toxicology, ecotoxicology data and environmental risk assessment reports.

 

5. Polymer simple registration and routine registration materials requirements

Regular registration	Simple registration
（1）Application form	（1）Application form
（2）Legal person certificate or business license, agency contract or agreement (with agent), power of attorney (with authorization)	（2）Legal person certificate or business license, agency contract or agreement (with agent), power of attorney (with authorization)
（3）Test report or data a	（3）Test report or data a
（4）Explanation on the necessity of information protection (e.g. applying for information protection)	（4）Explanation on the necessity of information protection (e.g. applying for information protection)
（5）Commitment letter for implementing or transmitting environmental risk control measures and environmental management requirements	（5）Commitment letter for implementing or transmitting environmental risk control measures and environmental management requirements
（6）Test organization condition data	（6）Test organization condition data
（7）Information b characterizing polymer identification, monomer residue in polymerization reaction, metal contained or cation thereof.	（7）Information b characterizing polymer identification, monomer residue in polymerization reaction, metal contained or cation thereof.
（8）Environmental risk assessment report a	（8）The judgment conclusion and basis of persistence, bioaccumulation and toxicity;
（9）Social and economic benefit analysis report (high hazard)	（9）Other information on the environmental and health hazard characteristics and environmental risks of the application materials.
（10）Other information on the environmental and health hazard characteristics and environmental risks of the application materials.

A After judging according to the nature of the material, if the data exemption conditions are met, the corresponding report or information can be exempted;

B Information characterizing polymer identification: including monomer/reactant list, molecular weight distribution diagram and polymerization mechanism process.

 

Data exemption conditions:

Polymers that meet the following three conditions at the same time can be exempted from submitting health toxicology, ecotoxicology data and environmental risk assessment reports when they go through simple or routine registration.

	Exemption conditions
1	The structure does not contain other metals except sodium, magnesium, potassium and calcium;
2	Insoluble in water, lipophilic solvents (n-octanol, n-heptane) and general solvents (tetrahydrofuran, dimethylformamide)
3	It is stable under acid and alkali conditions, that is, the stability tests at pH values of 4.0, 7.0, 9.0 and 1.2 (if it is physiologically important) all show stability

 

The acceptance, review and approval procedures for simple and routine registration of polymers are the same as those for general substances. The time limits for acceptance and approval are 5 and 20 working days respectively (which can be extended by 10 working days upon the approval of the person in charge of the competent department). The time limit for review is 30 days for simple registration and 60 days for routine registration. The applicant's supplementary materials in each stage are not included in the time limit. After approval, the corresponding production or import activities can be carried out.